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- Title
Safety evaluation of a lyophilized platelet-derived hemostatic product.
- Authors
Barroso, Jeffrey; Osborne, Barbara; Teramura, Gayle; Pellham, Esther; Fitzpatrick, Michael; Biehl, Ruth; Yu, Anna; Pehta, Joan; Slichter, Sherrill J.
- Abstract
<bold>Background: </bold>Hemorrhage causes significant morbidity and mortality in people aged <65 years. A lyophilized platelet-derived hemostatic agent (Thrombosomes) demonstrated hemostatic efficacy in animal models. We report the results of the first safety trial of autologous Thrombosomes given to normal subjects.<bold>Study Design and Methods: </bold>Ten subjects received autologous Thrombosomes prepared from their apheresis platelets, and five control subjects received a buffer solution. There were five cohorts, with three subjects per cohort (two in the Thrombosomes group and one in the control group). Doses escalated from 1/1,000 to 1/10 of a proposed efficacious dose. Cohorts 4 and 5 received the highest dose, but in Cohort 5, one-half the dose was infused 2 hours apart. Cohorts 1 through 3 were monitored for 42 days, Cohorts 4 and 5 were monitored for 60 days using hematology, coagulation, and chemistry assays and antibody testing.<bold>Results: </bold>There were no serious adverse events (AEs) and no subject withdrawals. There were eight treatment-related AEs (TRAEs) in 5 of 15 subjects (33%) (four in the Thrombosomes group and one in the control group). Of four subjects receiving the highest doses, three had TRAEs. One had elevated D-dimer, prothrombin fragment 1 + 2, and white blood cell count (subject had concurrent upper respiratory tract infection); one had T-wave inversions in precordial leads V2 and V3 without elevated troponin or symptoms; and one had a platelet autoantibody without change in platelet count. All subjects' TRAEs resolved by Day 21.<bold>Conclusion: </bold>There were no serious AEs in this small study. Thrombosomes were considered safe at the doses assessed. Future, larger trials will be needed to further assess safety and efficacy.
- Subjects
HEMOSTASIS; HEMAPHERESIS; BLOOD platelets; HLA histocompatibility antigens; HEPATECTOMY; BLOOD coagulation factors; CLINICAL trials; DRUG monitoring; FREEZE-drying; HEMOSTATICS; PEPTIDES; RESEARCH funding; FIBRIN fibrinogen degradation products; LEUKOCYTE count
- Publication
Transfusion, 2018, Vol 58, Issue 12, p2969
- ISSN
0041-1132
- Publication type
journal article
- DOI
10.1111/trf.14972